Job description

School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Clinical Trials

  • Attend all sponsor requested meeting such as Investigator meetings, SIV meeting, monitoring visits
  • Be an expert in your trial, know exclusion/inclusion criteria by heart
  • Become proficient in knowledge base regarding disease under study
  • Manage IRB correspondence- Update forms, recruiting letters, posters, renewals, amendments
  • Respond to and evaluate subject referrals- Screening/recruitment
  • Submit screening log to coordinating center/sponsor as required
  • Set up work flow with Home Health Nurse organization if required
  • Set up Clin Card account for each subject for reimbursement
  • Work closely with Investigational Drug service to order and pick up dispensed Investigational product
  • De-Id and upload patients’ DICOM data for all study procedures (ECG, Echo, MRI, CT and radiology)
  • Set up visit follow up with all patients, enter orders and link them in MC, schedule procedures and appts
  • Perform research study visits with subjects, see that all research procedures are performed
  • Perform all 6 MW Test and ECGs
  • Centrifuge, process, store and ship all blood samples required for study
  • Order, manage and store dry ice for sample shipment. Freeze batched samples as appropriate
  • Perform all required study documentation in MC, study file as applicable
  • Submit study subject test results, medications, evaluations etc. into EDC /database, complete Case Report Forms
  • Run weekly patient billing reports and reconcile all charges
  • Prepare for and schedule all monitoring visits

General Training

  • Attend/perform all required training, GCP/Compliance, Institutional OESO, research (CITI, HSR), attend DOCR Research Wednesdays whenever possible, MC & Billing training as needed
  • Heart center and Imaging CRU SOPs
  • Mastery of current ASE (American Society of Echocardiography) measurement guidelines
  • Mastery/knowledge of echo variables and standard ranges
  • Perform all recommended training to ensure proficiency with Maestro, OnCore and IRIS
  • Ensure proficiency with systems/software integral to the CDU: Showcase, IntelliSpace and Viewpoint, Box, C3

Tasks for providing services to other research teams: All Studies-

  • Coordinate closely with clinical team to ensure tests are scheduled and performed according to protocol requirements
  • Schedule Research patients in C3 & annotate for specific study requirements (Update charges and put in instructions, DE-ID information, coordinate resources/sonographers available to perform studies) - work with charge tech and scheduling team
  • Verify research patients have been correctly scheduled in C3 / Maestro, make corrections as needed
  • Create source documentation worksheets. Monitor data compliance with study worksheets
  • Worksheet completion (perform echo measurements) for all studies that require a site Echo CRF
  • Work with sonographers/coordinators to make sure echoes are performed correctly
  • Teach and retrain sonographers on specific measurements required for protocols
  • Provide feedback to Echo lab management as to quality of work performed for research echos
  • Deidentification of digital media: echo images, CPX reports and ECGs
  • Upload Digital data to shared drive for study teams, or upload to approved websites/vendors (AG MEDNET, WEBPAX, EPERNICUS, MEDIDATA, ETC.)
  • Schedule, perform and submit certification echoes for new studies-acquire images per protocol specifications
  • Webinar training for echo core labs and uploading systems for new studies
  • Read protocols and develop sonographer instructions for new studies, keep instructions updated
  • Update protocol lists- Master excel file, R drive folder, organization and updates
  • Coordinate with research teams for all data clarification and queries
  • Facilitate obtaining CDU signatures/CVs for SDL of Authority for study teams

Unit Specific PI Initiated Echo Studies

  • Attend all team meeting with investigative staff to review collection of data
  • Consent for all PI initiated echo studies
  • Log/Enroll Research patients in Maestro
  • Complete required source documentation in Maestro and send ICF to medical records
  • Archive all source documentation for Research according to GCP and Duke policy guidelines
  • Review echo studies, select the best for IIR, DE-ID, replicate IIRs for QC

Core Lab Work

  • Participate in conference calls and meetings for upcoming projects/ongoing projects, help to plan
  • Develop sonographer specific echo reading/measurement instructions specific to each study
  • Develop PP/training materials for site training, schedule conference training sessions to introduce protocol and teach site what data they need to collect
  • Set up IIR (Inter and intra reader variability), assign reads to team members
  • Arrange blinding schemata of data as required
  • Participate in routine Echo Core Lab SOP updates
  • Receive, review, de-identify image data from sites-log in, upload into secure research archive
  • Perform actual measurements, documentation and data entry
  • Train Core Lab sonographers on protocol when they are added to the reading team
  • Compile and organize data for analysis for each project
  • Maintain proficiency in performing all echo measurements and interpreting abnormal variables
  • Maintain proficiency in the ability to recognize abnormal cardiac physiology including but not limited to tamponade, restriction, left ventricular and right ventricular dysfunction and pulmonary hypertension.
  • Maintain proficiency in the ability to assess severity of valvular regurgitation and stenosis
  • Provide consistent feedback to participating study sites for quality control and protocol adherence
  • Perform remedial training of staff at participating study sites for quality control and protocol adherence
  • Coordinate with participating study sites to collect all regulatory documentation

Minimum Qualifications


Work requires sufficient education/training to acquire American Registry of Diagnostic Medical Sonographers (ARDMS) or Cardiovascular Credentialing International (CCI) certification in cardiac ultrasound, Registered Diagnostic Cardiac Sonographer (RDCS), or Registered Cardiac Sonographer (RCS).


Registry eligible. Registry preferred within 12 months of employment. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.




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Job No:
Posted: 2/14/2021
Application Due: 3/4/2021
Work Type: Full Time